Improving clinical outcomes by reducing bleeding in patients with non-ST-elevation acute coronary syndromes
Andrzej Budaj1, John W Eikelboom, Shamir R Mehta
1Postgraduate Medical School, Grochowski Hospital, Warsaw, Poland.
Insights
Bleeding in patients with acute coronary syndromes (ACS) significantly increases death risk. Using fondaparinux over enoxaparin in ACS patients reduced bleeding events and improved outcomes.
Area of Science:
- Cardiology
- Pharmacology
- Clinical Trials
Background:
- Bleeding complications in patients with coronary artery disease are associated with adverse clinical outcomes.
- Acute coronary syndromes (ACS) represent a critical manifestation of coronary artery disease.
Purpose of the Study:
- To investigate the incidence and clinical outcomes of bleeding in patients with ACS.
- To compare the safety and efficacy of fondaparinux versus enoxaparin in managing ACS patients.
Main Methods:
- Analysis of 20,078 patients with ACS from the OASIS-5 trial.
- Comparison of bleeding rates and associated outcomes between fondaparinux and enoxaparin treatment groups.
Main Results:
- Fondaparinux significantly reduced fatal bleeding (0.07% vs. 0.22%), major bleeding (2.2% vs. 4.2%), minor bleeding (1.1% vs. 3.2%), and transfusion needs compared to enoxaparin within the first 9 days.
- Major bleeding was associated with a four-fold increased hazard of death, myocardial infarction, or stroke within 30 days and a three-fold increased hazard within 180 days.
- One in six deaths within 30 days occurred in patients who experienced bleeding.
Conclusions:
- Bleeding is a critical determinant of both fatal and non-fatal outcomes in ACS patients.
- Employing a safer anticoagulant strategy, such as fondaparinux, during the initial 9 days of ACS treatment can substantially reduce morbidity and mortality.
Aims:
Bleeding in patients with coronary artery disease has been linked with adverse outcomes. We examined the incidence and outcomes after bleeding in 20 078 patients with acute coronary syndromes (ACS) enrolled in the OASIS-5 trial who were treated with fondaparinux or the low-molecular weight heparin, enoxaparin.
Methods And Results:
Nine hundred and ninety (4.9%) patients developed major bleeding and 423 (2.1%) developed minor bleeding. Fondaparinux compared with enoxaparin reduced fatal bleeding [0.07 vs. 0.22%, relative risk (RR) 0.30, 95% CI: 0.13-0.71], non-fatal major bleeding (2.2 vs. 4.2%, RR 0.52, 95% CI: 0.44-0.61), minor bleeding (1.1 vs. 3.2%, RR 0.34, 95% CI: 0.27-0.42), and need for transfusion (1.8 vs. 3.1%, RR 0.56, 95% CI: 0.47-0.61) during the first 9 days. One of every six deaths during the first 30 days occurred in patients who experienced bleeding. Cox proportional hazards model revealed that major bleeding was associated with about a four-fold increased hazard of death, myocardial infarction, or stroke during the first 30 days and about a three-fold increased hazard during 180 days of follow up.
Conclusion:
Bleeding in patients with ACS is a powerful determinant of fatal and non-fatal outcomes. Reducing the risk of bleeding using a safer anticoagulant strategy during the first 9 days is associated with substantial reductions in morbidity and mortality.
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